NCT06138470已完成不适用
Evaluation of the Effect of a Combination of Plants (saffron and Scutellaria) to Regulate Mood
Comercial Quimica Masso, S.A2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年5月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Evaluated mood regulation
研究概览
简要总结
The aim of this study is to confirm by a randomized double-blind controlled study the interest of a combination of saffron (Saffr'Activ®) and scutellaria (Scutell'up®) on the regulation of mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Woman or man, aged of 18 to 75 years;
- •Participant presenting a depressive episode, according to the DSM-5 definition;
- •Participant presenting a BDI ≥ 14 and ≤ 28 at the inclusion, corresponding to mild to moderate symptoms;
- •Participant with a recent episode of depression (less than 2 years), not managed by antidepressant or psychotherapeutic treatment;
- •Participant with a current depressive disorder not requiring, in the investigator's opinion, the initiation of antidepressant medication;
- •Provision of signed and dated informed consent form;
- •Stated willingness to comply with all study procedures and availability for the duration of the study;
- •French speaker.
排除标准
- •Participant with a depressive disorder of another nature or any other mental pathology (schizophrenia, bipolarity, addiction to alcohol or drugs...);
- •Participant at risk of suicide (determined by the Investigator, or HAMD item 3 score > 2) or having made a suicide attempt in the last 5 years;
- •Participant with depression for more than 2 years;
- •Participant undergoing psychotropic treatment (current or in the month prior to inclusion) (neuroleptic, anxiolytic, hypnotic);
- •Participant with a serious health problem for which the Investigator considers that it is not in the participant's interest to participate in the study;
- •Participant using products containing piperine or millpertuis, or having a known effect on mood within the last 4 weeks;
- •Pregnant or breastfeeding women, or those planning to become pregnant within the next 8 weeks;
- •Participant with an allergy or contraindication to any component of the study drug;
- •Participant unable to understand study information (mental or linguistic disability);
- •Participant who is participating or has participated in the previous month in another clinical trial.
结局指标
主要结局
Evaluated mood regulation
时间窗: Baseline and 6 weeks
observe a difference of the Beck Inventory Depression (BDI) score (adjusted for baseline), after 6 weeks of supplementation. All items are scored on a 4-point scale, ranging from 0 to 3.
次要结局
- Evaluated mood regulation(after 3 and 6 weeks of intervention and after 2 weeks after the end of intervention)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Dietary Supplementation on Body Fat CompositionDyslipidemiasPre-diabetesNCT06296251Brightseed150
已完成
不适用
Randomized, Placebo-Controlled Study of an Herbal Tea to Support LactationLactationNCT02190448Medical University of South Carolina60
Unknown
不适用
Dietary Supplementation on Gastrointestinal Barrier FunctionIntestinal PermeabilityNCT06262880Brightseed126
已完成
不适用
Effect of Consuming a Mixture of Extracts and DHA on the Mild Cognitive ImpairmentMild Cognitive ImpairmentNCT06254040Biosearch S.A.110
已完成
2 期
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)Major Depressive DisorderNCT00705003Massachusetts General Hospital142